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510(k) Data Aggregation

    K Number
    K120077
    Device Name
    COMED K-SERIES MANUAL WHEELCHAIR
    Date Cleared
    2012-05-14

    (125 days)

    Product Code
    Regulation Number
    890.3850
    Why did this record match?
    Applicant Name (Manufacturer) :

    DANYANG COMED HEALTHCARE CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Its intended use is to provide mobility to persons restricted to a sitting position.
    Device Description
    The Comed K-Series Manual Wheelchair is a user-propelled, manually operated folding wheelchair that is indicated for use indoors and outdoors, over smooth surfaces (all standard indoor flooring surfaces, concrete, asphalt and pocked dirt) that are free of large obstacles and inclines greater than 9 degrees. It consists of a mechanical steel frame and nylon upholstery. Designed to be lightweight and foldable, the model is approximately 18" wide, approximately 16" deep, has a weight capacity of 220lbs, and weighs approximately 42lbs.
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